REGRANEX® Gel contains becaplermin, a recombinant
human platelet-derived growth
factor (rhPDGF-BB) for topical
administration. Becaplermin is produced by recombinant
DNA technology
by insertion of the gene for
the B chain of platelet
derived growth factor (PDGF)
into the yeast, Saccharomyces cerevisiae. Becaplermin has a molecular
weight of approximately 25
KD and is a homodimer composed of two identical
polypeptide chains that
are bound together by disulfide
bonds. Becaplermin Concentrate is produced by Chiron Corp. and supplied
to OMJ Pharmaceuticals under a shared manufacturing arrangement. REGRANEX
Gel is a non-sterile, low bioburden, preserved, sodium
carboxymethylcellulose-based (CMC) topical
gel, containing the active ingredient
becaplermin and the following inactive ingredients: sodium
chloride, sodium acetate
trihydrate, glacial acetic
acid, water
for injection, and methylparaben,
propylparaben, and m-cresol as preservatives and l-lysine hydrochloride
as a stabilizer. Each gram of
REGRANEX Gel contains 100 µg of becaplermin.